Message 001
Communication from the Commission - TRIS/(2026) 1603
Directive (EU) 2015/1535
Notification: 2026/0301/FR
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20261603.EN
1. MSG 001 IND 2026 0301 FR EN 16-06-2026 FR NOTIF
2. France
3A. Ministères économiques et financiers
Direction générale des entreprises
SCIDE/SQUALPI - Pôle Normalisation et réglementation des produits
Bât. Sieyès -Teledoc 143
61, Bd Vincent Auriol
75703 PARIS Cedex 13
3B. Agence nationale de sécurité du médicament et des produits de santé (ANSM)
4. 2026/0301/FR - C10P - Pharmaceuticals
5. Decision amending the list of psychotropic substances
6. Muscimol and ibotenic acid are found in the mushroom Amanita muscaria and, in smaller amounts, in a few other Amanita species (Amanita pantherina).
7.
8. The ANSM’s draft decision concerns the inclusion of muscimol and its precursor, ibotenic acid, on the list of psychotropic substances. These psychoactive substances are found in the mushroom Amanita muscaria and, in smaller amounts, in a few other Amanita species (Amanita pantherina).
This draft decision follows, in particular, reports received by the French addiction vigilance network of consumption leading to serious effects, including one recent case requiring management in an intensive care unit. In all the reported cases, medical management was provided, with at least admission to the emergency department.
Ingestion of muscimol and ibotenic acid causes a characteristic pantherina-muscaria syndrome. The symptoms, which begin 30 minutes to 2 hours after ingestion, include neuropsychiatric manifestations alternating between excitement and depression, gastrointestinal manifestations and, in some cases, other symptoms such as tachycardia, hypertension, hyperthermia and mydriasis. The symptoms described are mainly psychiatric (agitation, delirium, confusion, hallucinations, tachypsychia, logorrhoea, euphoria) and neurological (clonus, convulsions, mydriasis, psychomotor retardation, coma, ataxia).
The latest reports indicate a change in the methods of consumption of these two substances, which are now incorporated in high concentrations into products marketed as foodstuffs (chocolate, sweets, etc.), in addition to the packets of dried mushrooms previously available.
Products containing them are available to the general public, particularly through sales made over the Internet or in CBD shops. Ingestion is the usual method of use. They are also found mixed with CBD and/or in e-liquid and, in such cases, are inhaled.
Inclusion on the list of psychotropic substances will therefore prohibit the sale of these substances and products containing them.
9. In view of the health risks to which their consumption gives rise, the draft text, which would classify ibotenic acid and muscimol as psychotropic substances, aims to prohibit the distribution of those substances and ensure better protection of public health.
According to reports received by the French addiction vigilance network, their use has led to serious effects, including one recent case that required management in an intensive care unit. In all the reported cases, medical management was provided, with at least admission to the emergency department.
Ingestion of muscimol and ibotenic acid causes a characteristic pantherina-muscaria syndrome. The symptoms, which begin 30 minutes to 2 hours after ingestion, include neuropsychiatric manifestations alternating between excitement and depression, gastrointestinal manifestations and, in some cases, other symptoms such as tachycardia, hypertension, hyperthermia and mydriasis. The symptoms described are mainly psychiatric (agitation, delirium, confusion, hallucinations, tachypsychia, logorrhoea, euphoria) and neurological (clonus, convulsions, mydriasis, psychomotor retardation, coma, ataxia).
In addition, these two substances are now incorporated in high concentrations into products presented as foodstuffs (chocolate, sweets, etc.), which are thus easily accessible to the general public, particularly through sales made over the internet or in CBD shops.
9a. Although use of Amanita muscaria by humans dates back a very long time, the sale of manufactured products containing muscimol appears to be a relatively recent phenomenon. The products on offer may include, for example, flavoured jelly sweets (gummies) or chocolate containing muscimol, muscimol e-liquid, herbs and resins, or even pre-rolled cones combining both CBD and muscimol, Amanita muscaria extracts, or dried mushrooms. Many online retail websites have been identified, but these products are also offered for sale in shops.
Various claims are made on these websites, such as promoting relaxation and stress relief, optimising physical performance, supporting digestive health, improving physical and mental health, strengthening the immune system, or presenting the products as a legal alternative to other regulated hallucinogenic substances.
Muscimol is a GABA analogue and has a chemical structure similar to that of GABA. It acts on GABAergic neurotransmission, stimulates the dopaminergic system and has an inhibitory effect on the serotonergic system.
Ibotenic acid is converted into muscimol by decarboxylation and is an analogue of glutamic acid. It is an agonist of NDMA (N-methyl-D-aspartate) and AMPA receptors.
Ingestion of muscimol and ibotenic acid causes a characteristic pantherina-muscaria syndrome. The symptoms, which begin 30 minutes to 2 hours after ingestion, include neuropsychiatric manifestations alternating between excitement and depression, gastrointestinal manifestations and, in some cases, other symptoms such as tachycardia, hypertension, hyperthermia and mydriasis.
For muscimol, the minimum active dose on the central nervous system in humans is estimated at 6 mg, with a toxic dose ranging from 8 to 15 mg.
For ibotenic acid, the minimum active dose in the central nervous system is estimated at 30 mg, taking into account its prodrug properties.
The ANSM commissioned an addiction vigilance investigation through its addiction vigilance network in order to assess the psychoactive effects of muscimol and its precursor, their potential for abuse and dependence, and the risk to public health associated with their circulation and, by extension, that of the higher fungi containing them.
Data from the addiction vigilance network up to 20 August 2024:
As at 20 August 2024, the network had collected 10 spontaneous reports involving hallucinogenic Amanita mushrooms or muscimol. Of these 10 cases, eight involved an Amanita mushroom (Amanita muscaria n = 7 and Amanita pantherina n = 1), whereas the remaining two cases involved muscimol in the form of gummies.
Overall, seven of the 10 cases occurred after 2020, and six were reported in 2023 and 2024.
The symptoms described are mainly psychiatric (agitation, delirium, confusion, disorientation, hallucinations, tachypsychia, aggression, logorrhoea, euphoria) and neurological (clonus, convulsions, mydriasis, psychomotor retardation, coma, ataxia). These symptoms are consistent with those described in pantherina-muscaria syndrome.
In all cases, medical management was provided, with at least admission to the emergency department. Six out of 10 cases met a severity criterion: admission to an intensive care unit (four cases) and transfer to a psychiatric ward (one case). The sixth case, which did not present any criterion of somatic or psychiatric severity, involved a 17-year-old who had ingested mushrooms.
Where information is available, the outcome was favourable. The users were predominantly men (eight out of 10 cases) with a median age of 35. The reported desired effects were mainly stimulant, hallucinogenic and sometimes calming.
Data from the French poison control centre network (CAP-TV) from 1 January 2015 to 31 October 2024:
The analysis report of the data on muscimol a iden
9b. Inclusion on the list of psychotropic substances results in a ban on activities involving them, in particular their sale, importation and exportation, unless expressly authorised by the ANSM in accordance with Article R. 5132-88 of the Public Health Code (Article R. 5132-88 – Public Health Code – Légifrance).
However, the draft measure does not appear to have a significant effect on the internal market.
The European Commission could include muscimol in the Novel Food Catalogue as an unauthorised food, as is the case for CBD, or as a psychoactive substance prohibited in food, as with nicotine.
Why have these solutions been rejected?
At this stage, the European Commission has not taken up this proposal.
Why is the chosen measure the least restrictive means of achieving the objective?
Another measure could have been to include these substances on the list of narcotic drugs.
9c. Are the restrictions imposed by the measure proportionate to the importance of the public interest objective pursued or, where appropriate, to the seriousness of the risk and the likelihood of it materialising?
The measure appears proportionate in view of the risks of potentially fatal poisoning associated with the use of muscimol and ibotenic acid, which are currently sold in various forms; their very wide availability (in shops and online), including for children (in the form of sweets); and the resulting risks to public health.
10. References to the basic texts:
11. Yes
12. The urgency of the measure is justified by the risks to public health posed by the sale and consumption of products containing muscimol and ibotenic acid, including dried mushrooms. Their consumption may expose consumers to unintended effects, with serious consequences for their health that may require emergency medical management.
It should also be stressed that their presence in products presented as foodstuffs is all the more problematic because consumers may be unaware of it and because the presentation of those products is particularly appealing to children. Lastly, their concentration is generally high.
Accordingly, given that the vast majority of reported cases have required management by a healthcare professional, either in the emergency department or in an intensive care unit, and given the availability of these products in various attractive forms, these substances should classified as psychotropic substances as a matter of urgency in order to prohibit their sale and thereby limit the risk to public health.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
